Healthy AdultPhase 1NCT07609875
A Phase I Single and Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of HS-10522 in Healthy Chinese Participants and Chinese Participants With Mild Hypertension
A Phase 1 study testing HS-10522 in people with Healthy Adult and Hypertension, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult, Hypertension
- What is being tested?
- HS-10522
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 3 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
- For all participants:
- Able to understand the procedures and methods of the study, willing to strictly adhere to the clinical trial protocol to complete the study, and voluntarily sign the Informed Consent Form (ICF).
- Male or female participants aged 18 to 55 years (inclusive) at the time of signing ICF.
- At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive).
Who cannot join
- Abnormal vital signs, physical examination findings, or laboratory test results at screening that are deemed clinically significant by the investigator.
- Presence of orthostatic hypotension or orthostatic tachycardia at screening.
- Clinically significant abnormal findings on the 12-lead ECG at screening, as judged by the investigator.
- Use of any medication within 2 weeks or 5 half-lives (whichever is longer) prior to screening, or anticipation of needing such medication during the trial.
- Known secondary causes of hypertension, or diseases that may affect adrenal function (e.g., renal artery stenosis, poorly controlled or untreated hyperthyroidism, poorly controlled or untreated hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome).
- Participation in any other clinical trial of a drug or medical device within 12 weeks prior to screening, with receipt of at least one dose (including placebo), or currently within 5 half-lives of the last dose of the investigational product (whichever is longer).
- Participants who, in the opinion of the investigator, are likely to be non-compliant or are unsuitable for participation in this trial for any other reason.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HS-10522 Tablets in Healthy Chinese Participants and Chinese Participants With Mild Hypertension
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.
- Conditions
- Healthy Adult, Hypertension
- Being tested
- HS-10522, HS-10522 Placebo
- Keywords
- hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10522Drug
HS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily
HS-10522 PlaceboDrug
HS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily
| Study group | Role | What they receive |
|---|---|---|
| HS-10522 | Experimental | Not described Receives: Drug: HS-10522 |
| HS-10522 Placebo | Placebo comparator | Not described Receives: Drug: HS-10522 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events following single and multiple doses of HS-10522 in healthy participants and participants with mild hypertension
Safety and tolerability will be assessed by comparison of number of adverse events between groups
Measured: SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing
Secondary outcomes (10)
Maximum plasma concentration (Cmax)
Measured: -0.5 to 120 hour after dosing
time to maximum plasma concentration (Tmax)
Measured: -0.5 to 120 hour after dosing
area under the curve (AUC)
Measured: -0.5 to 120 hour after dosing
half-life
Measured: -0.5 to 120 hour after dosing
apparent volume of distribution (Vz/F)
Measured: -0.5 to 120 hour after dosing
apparent oral clearance (CL/F) of HS-10522
Measured: -0.5 to 120 hour after dosing
Plasma aldosterone following single and multiple oral doses of HS-10522
Measured: 0 to 96 hour after dosing
Cortisol following single and multiple oral doses of HS-10522
Measured: 0 to 96 hour after dosing
Metabolites levels following single and multiple oral doses of HS-10522
Measured: 0 to 96 hour after dosing
(Exploratory) Mean seated systolic and diastolic blood pressure change compared with baseline
Blood pressure measurement will be performed only in MAD part
Measured: 14 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion20 Jan 2027 (estimated)
- Study completion3 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609875
- Sponsor's protocol ID
- HS-10522-101
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HS-10522 Tablets in Healthy Chinese Participants and Chinese Participants With Mild Hypertension
- ClinicalTrials.gov ID
- NCT07609875
- Acronym / sponsor ID
- HS-10522-101
- Conditions
- Healthy Adult, Hypertension
- Keywords
- hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 3 Feb 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10522 | Experimental | Drug: HS-10522 |
| HS-10522 Placebo | Placebo comparator | Drug: HS-10522 Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- -
- Able to understand the procedures and methods of the study, willing to strictly adhere to the clinical trial protocol to complete the study, and voluntarily sign the Informed Consent Form (ICF).
- Male or female participants aged 18 to 55 years (inclusive) at the time of signing ICF.
- At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive).
Key exclusion criteria (7 listed)
- Abnormal vital signs, physical examination findings, or laboratory test results at screening that are deemed clinically significant by the investigator.
- Presence of orthostatic hypotension or orthostatic tachycardia at screening.
- Clinically significant abnormal findings on the 12-lead ECG at screening, as judged by the investigator.
- Use of any medication within 2 weeks or 5 half-lives (whichever is longer) prior to screening, or anticipation of needing such medication during the trial.
- Known secondary causes of hypertension, or diseases that may affect adrenal function (e.g., renal artery stenosis, poorly controlled or untreated hyperthyroidism, poorly controlled or untreated hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10522HS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily | Drug | HS-10522 |
| HS-10522 PlaceboHS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily | Drug | HS-10522 Placebo |
Primary outcome
Incidence of adverse events following single and multiple doses of HS-10522 in healthy participants and participants with mild hypertension
Time frame: SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing
Safety and tolerability will be assessed by comparison of number of adverse events between groups
10 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: -0.5 to 120 hour after dosing
time to maximum plasma concentration (Tmax)
Time frame: -0.5 to 120 hour after dosing
area under the curve (AUC)
Time frame: -0.5 to 120 hour after dosing
half-life
Time frame: -0.5 to 120 hour after dosing
apparent volume of distribution (Vz/F)
Time frame: -0.5 to 120 hour after dosing
apparent oral clearance (CL/F) of HS-10522
Time frame: -0.5 to 120 hour after dosing
Plasma aldosterone following single and multiple oral doses of HS-10522
Time frame: 0 to 96 hour after dosing
Cortisol following single and multiple oral doses of HS-10522
Time frame: 0 to 96 hour after dosing
Metabolites levels following single and multiple oral doses of HS-10522
Time frame: 0 to 96 hour after dosing
(Exploratory) Mean seated systolic and diastolic blood pressure change compared with baseline
Time frame: 14 days after dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
Related trials for Healthy Adult
RecruitingPhase 4
Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans
Healthy Adult Participants, Age 65 and Older
Recruiting
Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults
Aging, Supplementation
RecruitingPhase 1
Phase Ia Study of MST-931 in Healthy Adult Subjects
Ankylosing Spondylitis (AS)
Not yet recruiting
Abdominal Air-Pressure Resistance Versus Abdominal Weight Training for Improving Diaphragm Function in Healthy Young Adults
Diaphragm Thickness, Dyspnoea
RecruitingPhase 1
A Study to Assess the Relative Bioavailability of Irafamdastat (BMS-986368) and to Assess the Food Effect on the Pharmacokinetics of Irafamdastat in Healthy Adult Participants
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10522 in people with Healthy Adult and Hypertension, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events following single and multiple doses of HS-10522 in healthy participants and participants with mild hypertension (time frame: SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.